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CompletedNCT03490435Updated Mar 26, 2020

Intestinal Parasites in Inhabitants of Kuyavian-Pomeranian Province in Poland

An observational study in Intestinal Disease, Parasitic and Chronic Disease, sponsored by Nicolaus Copernicus University. Completed at 1 site in Poland. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-26.

Primary conditionChronic Disease(the registry's first term)UnverifiedIs this wrong?Chronic Disease is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Nicolaus Copernicus University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
22
Ages
3 Years and older
Sex
All
01

Study summary

The goal of the proposed study is to assess the prevalence of intestinal parasitic diseases in adults and children. These invasions are included to "dirty hand diseases" (per os invasions), therefore it applies mainly preschool children.

Read the detailed description

It is estimated that 75% of the world's population is infected with parasites and although parasitic diseases are mostly observed in the poor tropical and subtropical countries, there are also many diseases caused by parasites in Poland. In Poland, particular attention is paid to the following parasitic diseases closely related to the digestive system: giardiasis, taeniasis (including cysticercosis), ascariasis, cryptosporidiosis, toxoplasmosis, trichinosis, echinococcosis.

Symptoms of such invasions may include: allergic rhinitis of unknown origin, chronic fatigue or food intolerance. Moreover, many of them are asymptotic, therefore the study group will consist of both healthy people and individuals with undiagnosed diseases or/and chronic symptoms.

02

Conditions studied

  • Intestinal Disease, Parasitic
  • Chronic Disease

Keywords

  • Per os invasions
  • Giardiasis
  • Toxoplasmosis
  • Taeniasis
  • Cryptosporidiosis
  • Trichinosis
  • Ascariasis
  • Echinococcosis
03

In context

Chronic Disease Unverified

781 studies on the registry are indexed under Chronic Disease; 144 are open to participants now.

This study's enrollment of 22 is below the median of 461 across 188 observational studies indexed under Chronic Disease.

Browse Chronic Disease studies →

Lead sponsor

Nicolaus Copernicus University is the lead sponsor of 19 studies on the registry; 4 are open to participants now.

Compared within Chronic Disease, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy people and inviduals with undiagnosed diseases or/and chronic symptoms such as: hay fever, skin and food allergies or eg. chronic fatigue.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy and ailing individuals
  • men and females
  • adults and children

Exclusion criteria

Exclusion Criteria:

  • the participants were not be: incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
22 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Study participants

    Both healthy and ailing individuals, both sex, including adults and children.

    Diagnostic Test: Tests for diagnosis of intestinal parasitic diseases

Interventions

  • Diagnostic testTests for diagnosis of intestinal parasitic diseases

    Feces testing: 1. fresh fecal samples will be used to preparing direct (saline and iodine wet) mounts using supplementary techniques (flotation, sedimentation), as well as temporary mounts (hematoxylin and trichrome staining). Other technique of fresh fecal samples examination will be ParaSys™ 2. A non-preserved stool samples will be stored below -20°C. Defrosted fecal specimen will be subjected to enzyme-linked immunosorbent assays (ELISA) - Giardia antigen test (coproantigens)

06

What researchers measure

Primary outcomes

  1. Intestinal parasites

    The fecal samples will be assessed qualitavely in terms of life forms of parasites present in human intestine, i.e.: eggs and larvas of flukes, tapeworms and nematodes, as well as protozoa trophozoites and cysts.

    Time frame: 1 day (single evaluation of current samples)

  2. Giardia antigen test

    Stool test for Giardia lamblia antigen (ELISA kit)

    Time frame: 1 day (single evalutaion of all samples through study completion)

07

Study locations

1 site
  • The Chair of Medical Biology, Collegium Medicum of Nicolaus Copernicus University
    Bydgoszcz, Kujawsko-Pomorskie 85-092, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Dec 2019, 22 months.

Of 86 non-industry observational studies under Chronic Disease, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 53. This study's 22 months is below that.

Counting every sponsor, half of 91 studies reached it within 37 months; a quarter within 14.

Chronic Disease covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 21, 2018
First posted
Apr 6, 2018
StartActual
Feb 17, 2018
Primary completionActual
Dec 31, 2019
CompletionActual
Dec 31, 2019
Last update
Mar 26, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03490435
Lead sponsor
Nicolaus Copernicus University
Responsible party
Paweł Sutkowy (Assistant professor, Nicolaus Copernicus University) — Principal investigator
First posted
Apr 6, 2018
Start date
Feb 17, 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Mar 26, 2020

Study contacts

Paweł Sutkowy, PhD
principal investigator · Nicolaus Copernicus Univeristy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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